Abstract:

A universal blister package for the distribution of medical instruments
includes a tray having a resilient film and a retainer having a resilient
film. The tray and the retainer are shaped and dimensioned for selective
engagement in a manner creating a storage space between the film of the
tray and the film of the retainer for accommodating a medical instrument
between the tray and the retainer.

Claims:

1. A universal blister package for distribution of medical instruments,
comprising:a tray including a resilient film; anda retainer including a
resilient film;wherein the tray and the retainer are shaped and
dimensioned for selective engagement in a manner creating a storage space
between the film of the tray and the film of the retainer for
accommodating a medical instrument between the tray and the retainer.

2. The blister package according to claim 1, wherein the tray includes a
tray body including a base from which a plurality of upwardly extending
sidewalls depend, the base includes a perimeter edge and the upwardly
extending sidewalls are positioned along the perimeter edge of the base;
and the retainer includes a retainer body including an open base from
which a plurality of downwardly extending sidewalls depend, the base
includes a perimeter edge and the downwardly extending sidewalls are
positioned along the perimeter edge of the base.

3. The blister package according to claim 2, wherein the base and upwardly
extending sidewalls of the tray body define an exterior surface of the
tray body that is substantially convex, the base and upwardly extending
sidewalls of the retainer body define an interior surface of the retainer
body in the shape of a recess in which a medical product is supported,
the base and downwardly extending sidewalls of the tray body define an
exterior surface of the tray body, and the base and downwardly extending
sidewalls of the retainer body define an interior surface of the retainer
body in the shape of a recess in which the medical instrument is
retained.

4. The blister package according to claim 3, wherein the film of the tray
is applied along the interior surface of the tray body and the film of
the retainer is applied along the interior surface of the retainer body.

5. The blister package according to claim 4, wherein the film includes a
first surface facing away from the base of the tray body and a second
surface facing the base of the tray body, and the film includes a first
surface facing away from the base of the retainer body and a second
surface facing the base of the retainer body.

6. The blister package according to claim 5, wherein the film is adhered
to a ledge located on the interior surface of the upwardly extending
sidewalls making up the tray body, wherein the medical instrument is
packaged such that it is placed upon the first surface of the film with
the film between the base of the tray body and the medical instrument, as
well as supporting and spacing the medical instrument away from the base
of the tray body, and wherein the film is adhered to a ledge located on
the interior surface of the upwardly extending sidewalls making up the
retainer body, wherein the medical instrument is packaged such that it is
placed upon the first surface of the film with the film between the base
of the retainer body and the medical instrument, as well as supporting
and spacing the medical instrument away from the base of the retainer
body.

7. The blister package according to claim 6, wherein upper edges of the
upwardly extending sidewalls of the tray body are provided with coupling
members shaped and dimensioned to receive mating coupling members at the
edges of the downwardly extending sidewalls of the retainer body.

8. The blister package according to claim 7, wherein the assembled blister
package is then wrapped and sealed in a sheet.

Description:

BACKGROUND OF THE INVENTION

[0001]1. Field of the Invention

[0002]The invention relates to packaging. More particular, the invention
relates to universal packaging for medical instruments.

[0003]2. Description of the Related Art

[0004]As those familiar with the medical instrument industry will
certainly appreciate, products must be shipped and packaged in a manner
that maintains their sterility and protects the instruments during
shipping. As such, most medical instrument packaging is constructed in a
manner specific to the instrument at issue. As such, substantial tooling
and costs are applied in developing individual unique packaging for each
medical instrument.

[0005]With the foregoing in mind, there is a need for packaging offering a
mechanism whereby the costs and time expenditures associated with prior
packaging techniques are obviated. The present invention provides such
packaging.

SUMMARY OF THE INVENTION

[0006]It is, therefore, an object of the present invention to provide a
universal blister package for the distribution of medical instruments.
The blister package includes a tray having a resilient film and a
retainer having a resilient film. The tray and the retainer are shaped
and dimensioned for selective engagement in a manner creating a storage
space between the film of the tray and the film of the retainer for
accommodating a medical instrument between the tray and the retainer.

[0007]It is also an object of the present invention to provide a blister
package wherein the tray includes a tray body having a base from which a
plurality of upwardly extending sidewalls depend. The base includes a
perimeter edge and the upwardly extending sidewalls are positioned along
the perimeter edge of the base. The retainer includes a retainer body
having an open base from which a plurality of downwardly extending
sidewalls depend. The base includes a perimeter edge and the downwardly
extending sidewalls are positioned along the perimeter edge of the base.

[0008]It is another object of the present invention to provide a blister
package wherein the base and upwardly extending sidewalls of the tray
body define an exterior surface of the tray body that is substantially
convex, the base and upwardly extending sidewalls of the retainer body
define an interior surface of the retainer body in the shape of a recess
in which a medical product is supported, the base and downwardly
extending sidewalls of the tray body define an exterior surface of the
tray body, and the base and downwardly extending sidewalls of the
retainer body define an interior surface of the retainer body in the
shape of a recess in which a medical instrument is retained.

[0009]It is a further object of the present invention to provide a blister
package wherein the film of the tray is applied along the interior
surface of the tray body and the film of the retainer is applied along
the interior surface of the retainer body.

[0010]It is also an object of the present invention to provide a blister
package wherein the film includes a first surface facing away from the
base of the tray body and a second surface facing the base of the tray
body, and the film includes a first surface facing away from the base of
the retainer body and a second surface facing the base of the retainer
body.

[0011]It is another object of the present invention to provide a blister
package wherein the film is adhered to a ledge located on the interior
surface of the upwardly extending sidewalls making up the tray body,
wherein the medical instrument is packaged such that it is placed upon
the first surface of the film with the film between the base of the tray
body and the medical instrument, as well as supporting and spacing the
medical instrument away from the base of the tray body, and wherein the
film is adhered to a ledge located on the interior surface of the
upwardly extending sidewalls making up the retainer body, wherein the
medical instrument is packaged such that it is placed upon the first
surface of the film with the film between the base of the retainer body
and the medical instrument, as well as supporting and spacing the medical
instrument away from the base of the retainer body.

[0012]It is a further object of the present invention to provide a blister
package wherein upper edges of the upwardly extending sidewalls of the
tray body are provided with coupling members shaped and dimensioned to
receive mating coupling members at the edges of the downwardly extending
sidewalls of the retainer body.

[0013]It is also an object of the present invention to provide a blister
package wherein the assembled blister package is then wrapped and sealed
in a sheet.

[0014]Other objects and advantages of the present invention will become
apparent from the following detailed description when viewed in
conjunction with the accompanying drawings, which set forth certain
embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]FIG. 1 is an exploded perspective view of a package in accordance
with a first embodiment of the present invention.

[0016]FIG. 2 is a perspective view of the package shown with reference to
FIG. 1 with a medical instrument ready for packaging.

[0017]FIGS. 3 and 4 respectively show a perspective view and a cross
sectional view of the medical instrument sealed within the package.

[0018]FIGS. 5 and 6 respectively show a perspective view and a cross
sectional view of the medical instrument sealed within the package with
TYvEK wrapping the package.

[0019]FIG. 7 is an exploded perspective view of a medical instrument being
placed into a tray of a package in accordance with a second embodiment of
the present invention.

[0020]FIG. 8 is a perspective view of the tray shown with reference to
FIG. 7 with a medical instrument ready for packaging.

[0021]FIG. 9 is a perspective view of the medical instrument ready for
packaging with a pouch positioned about the tray.

[0022]FIGS. 10 and 11 respectively show a perspective view and a cross
sectional view of the medical instrument sealed in accordance with the
present invention.

[0024]The detailed embodiment of the present invention is disclosed
herein. It should be understood, however, that the disclosed embodiment
is merely exemplary of the invention, which may be embodied in various
forms. Therefore, the details disclosed herein are not to be interpreted
as limiting, but merely as a basis for teaching one skilled in the art
how to make and/or use the invention.

[0025]Referring to FIGS. 1 to 6, a universal blister package 10 is
disclosed. The present blister package 10 is particularly designed for
use in the distribution of medical instruments 12, although those skilled
in the art will appreciate the concepts underlying the present blister
package 10 may be applied to the distribution of various products without
departing from the spirit of the present invention. The present blister
package 10 eliminates the need for the design and manufacture of a custom
blister package for each new product developed and also eliminates the
need for many, if not most, of the blister packages currently being used
in production.

[0026]In accordance with a preferred embodiment, the present blister
package 10 includes a tray 14 and a retainer 16. As will be discussed
below in greater detail, the tray 14 and retainer 16 are shaped and
dimensioned for selective engagement in a manner creating a storage space
18 accommodating a medical instrument(s) 12 between the tray 14 and the
retainer 16.

[0027]The tray 14 includes a tray body 20. The tray body 20 is preferably
composed of thermoformed PETG (polyethylene terephthalate glycol). The
tray body 20 is generic and may support a variety of medical instruments.
The tray body 20 is, therefore, constructed with a base 22 from which a
plurality of upwardly extending sidewalls 24 extend. The base 22 includes
a perimeter edge 26 and the upwardly extending sidewalls 24 are
positioned along the perimeter edge 26 of the base 22.

[0028]The base 22 and upwardly extending sidewalls 24 define an exterior
surface 28 that is substantially convex. The base 22 and upwardly
extending sidewalls 24 define an interior surface 30 in the shape of a
recess 32 in which a medical product is supported in a manner discussed
below in greater detail.

[0029]The tray 14 further includes a thin resilient film 34. In accordance
with a preferred embodiment of the present invention, the thin resilient
film is a medical grade polyurethane material, although is contemplated
other resilient film materials could be employed within the spirit of the
present invention. For example, it is contemplated the film could be a
polypropylene or polyethylene type material providing that the material
properties meet the performance requirements that enable functionality of
the present package.

[0030]The film 34 is applied along the interior surface 30 of the tray
body 20. In particular, the film 34 includes a first surface 36 facing
away from the base 22 of the tray body 20 and a second surface 38 facing
the base 22 of the tray body 20. The film 34 is adhered to a ledge 40
located on the interior surface 30 of the upwardly extending sidewalls 24
making up the tray body 20. In practice, the medical instrument(s) 12 is
packaged such that it is placed upon the first surface 36 of the film 34
with the film 34 between the base 22 of the tray body 20 and the medical
instrument(s) 12, as well as supporting and spacing the product away from
the base 22 of the tray body 20.

[0031]The blister package 10 further includes a retainer 16. The retainer
16 is constructed much like the tray 14 and includes a retainer body 42.
As such, the retainer body 42 is constructed with an open base (or
structural support rim) 44 from which a plurality of downwardly extending
sidewalls 46 depend. The base 44 includes a perimeter edge 48 and the
downwardly extending sidewalls 46 are positioned along the perimeter edge
48. The base 44 and downwardly extending sidewalls 46 define an exterior
surface 50. The base 44 and downwardly extending sidewalls 46 define an
interior surface 52 in the shape of a recess 54 in which a medical
instrument(s) 12 is retained in a manner discussed below in greater
detail.

[0032]As with the tray 14, the retainer 16 also includes a thin resilient
film 56 adhered to a ledge 58 within the retainer body 42. In particular,
the film 56 is applied along the interior surface 52 of the retainer body
42. The film 56 includes a first surface 60 facing away from the base 44
of the retainer body 42 and a second surface 62 facing the base 44 of the
retainer body 42. The film 56 is adhered to the ledge 58 located on the
interior surface 52 of the downwardly extending sidewalls 46 making up
the retainer body 42. As will be discussed below in greater detail, the
medical instrument(s) 12 is packaged such that it is placed on the first
surface 60 of the film 56 with the film 56 between the base 44 of the
retainer 16 and the medical instrument(s) 12. As with the tray 14, the
film 56 supports and retains the medical instrument(s) 12 in a spaced
relationship relative to the base 44 of the retainer body 42.

[0033]In practice, the medical instrument(s) 12 is placed within the tray
14 and upon the first surface 36 of film 34 mounted therein. As shown in
the appended drawings, during packaging of a medical instrument(s) 12 the
tray 14 is preferably supported in a horizontal orientation with the
recess 32 and film 34 facing upwardly and ready to receive the medical
instrument(s) 12. Although this orientation is preferred and used in
describing the operation of the present blister package 10, it is
contemplated other orientations are possible without departing from the
spirit of the present invention. Once the medical instrument(s) 12 is
placed in the recess 32 defined by the tray 14 and upon the first surface
36 of the film 34, the retainer 16 is positioned above the tray 14 and
the downwardly extending sidewalls 46 of the retainer body 42 are engaged
with the upwardly extending sidewalls 24 of the tray body 20 to form a
cavity, or storage space 18, in which the medical instrument(s) 12 is
positioned.

[0034]In accordance with a preferred embodiment, the upper edges 64 of the
upwardly extending sidewalls 24 of the tray body 20 are provided with
coupling members 66 shaped and dimensioned to receive mating coupling 68
members at the edges 70 of the downwardly extending sidewalls 46 of the
retainer body 42. The coupling members 68 of the respective tray body 20
and retainer body 42 preferable snap into engagement to hold the retainer
16 relative to the tray 14. By snapping the retainer 16 in place over the
tray 14, and as a result of the mechanical nature of the films 34, 56,
the medical instrument(s) 12 is suspended within the blister package 10;
that is, the medical instrument(s) 12 is supported generally between the
tray body 20 and the retainer body 42 with the respective films 34, 56 of
the tray 14 and retainer 16 holding the medical instrument(s) 12 in a
spaced relationship from the respective bases 22, 44 of the tray body 20
and retainer body 42.

[0035]The assembled blister package 10 is then wrapped and sealed with
TYVEK® (a sheet of man-made fibers, for example, a spunbonded olefin)
72 in a conventional manner in order to ensure sterility. While TYVEK is
disclosed in accordance with a preferred embodiment, it is contemplated
other suitable medical grade lidding materials may be used without
departing from the spirit of the present invention. As those skilled in
the art will certainly appreciate, it is contemplated the present blister
package 10 will be constructed in various sizes to accommodate several
product families.

[0036]In accordance with an alternate embodiment, and with reference to
FIGS. 7 to 12, a package 110 is disclosed which includes an inner tray
114 with a vacuum sealed pouch 116 secured thereabout in a manner
securely holding a medical instrument(s) 112 between the inner tray 114
and the pouch 116. More particularly, the package 110 includes a rigid or
semi-rigid inner tray 114. The inner tray 114 is preferably manufactured
from paperboard, foam or plastic, although other materials may be used
without departing from the spirit of the present invention. The inner
tray 114 includes a base 118 with raised sidewalls 120 extending
therefrom. The base 118 includes a perimeter edge 122 and the sidewalls
120 are positioned along the perimeter edge 122. In accordance with a
preferred embodiment, the inner tray 114 is sized such that a medical
instrument 112, or a set of medical instruments, may be laid out along
the base 118 of the inner tray 114 while still providing clearance
between the instrument(s) and between the instrument(s) and the sidewalls
120 of the inner tray 114.

[0037]The package 110 further includes a nonporous plastic film bag or
pouch 116 shaped and dimensioned to fit over the inner tray 114 with the
medical instrument(s) 112 positioned thereon. As will be discussed below
in greater detail, the pouch 116 is constructed to permit the formation
of a sealed vacuum environment within the pouch 116.

[0038]As such, and in practice, the inner tray 114, with the medical
instrument(s) 112 in its designated position, is positioned within the
pouch 116. The air within the pouch 116 is drawn from the pouch 116 via a
vacuum, evacuating the space within the pouch 116. The pouch 116 is then
immediately vacuum sealed with all air removed from the interior of the
pouch 116.

[0039]Although it is contemplated evacuation and sealing of the pouch 116
is to be achieved through the implementation of an automated process, it
is further contemplated evacuation and sealing may be achieved through
manual compression of the pouch and inner tray 114 with soft foam 176
during sealing, thus pushing the air out of the pouch 116 (see FIG. 12).

[0040]With the medical instrument(s) 112 sealed within the pouch 116 as
described above, the film of the pouch 116 is drawn into engagement with
the inner tray 114 along the exposed top and bottom surfaces 124, 126 of
the inner tray 114 and directly around the medical instrument(s) 112
precluding movement of the medical instrument(s) 112 relative to the
inner tray 114 and thereby retaining the medical instrument 112 against
the base of the inner tray 114. As such, the present package 110 is
composed of an inner tray 114 with a vacuum sealed pouch 116 secured
thereabout in a manner securely holding a medical instrument 112 between
the inner tray 114 and the pouch 116. The present package 110 precludes
the movement of the device features, such as, for example, handles,
triggers, etc.

[0041]The present invention allows faster product launches due to its
ability to provide a more generic universal packaging component, thus
eliminating the need for custom formed tooling in the production of a
package. The present invention also provides a benefit for products with
anticipated design changes that normally would require package tooling
revisions and revalidations to implement design changes.

[0042]Possible additional features of the present invention includes the
ability of a manufacturer to print device outlines 121 in the bottom or
other exposed surfaces of the inner tray or on separate paper inserts
into the inner tray that show the planned positioning of the medical
instruments into the inner tray and/or require product labeling printed
on the bottom of the inner tray or on a separate sheet inserted into the
bag such that the printed pouches would not be required. In addition, it
is contemplated the inner tray could either be made of foam or have a
foam layer inserted into the bottom of the inner tray to provide
cushioning to the product.

[0043]The present invention also allows for irregular or sharp features of
a medical product to be provided with a separate protective cover of foam
or paperboard or plastic such that when the air is removed from the
pouch, the cover remains between the pouch material and the medical
product to prevent abrasion or holes in the pouch from the product.

[0044]It is further contemplated that the present invention will provide a
ready indication of breach of sterility in that a hole in the pouch will
inherently result in a loose fitting pouch due to the ingress of
additional air into the interior of it versus otherwise sealed package
product without holes in the pouch.

[0045]While the preferred embodiments have been shown and described, it
will be understood that there is no intent to limit the invention by such
disclosure, but rather, is intended to cover all modifications and
alternate constructions falling within the spirit and scope of the
invention.